Schizophrenia MedDRA version: 14.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Brexpiprazole
Product Code: Lu AF41156, OPC-347112
Pharmaceutical Form: Tablet
INN or Proposed INN: Brexpiprazole
CAS Number: N/A
Current Sponsor code: Lu-AF41156
Other descriptive name:
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The patient has completed the lead-in study 14644A. • The patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator. • The patient agrees to protocol-defined use of effective contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 137 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: • The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14644A. • The patient has a clinically significant unstable illness diagnosed during Study 14644A. • The patient, in the opinion of the investigator or according to Columbia- Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide. • The patient has an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant. • The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Long-term safety and tolerability of brexpiprazole;Secondary Objective: - Effect of brexpiprazole in patients with schizophrenia on psychotic symptoms - Effect of brexpiprazole in patients with schizophrenia on global clinical impression - Effect of brexpiprazole in patients with schizophrenia on response rate - Effect of brexpiprazole in patients with schizophrenia on personal and social performance ;Primary end point(s): -Safety and tolerability -Risk of suicidality;Timepoint(s) of evaluation of this end point: -Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP). -Up to 52 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Change from baseline in psychotic symptoms (Positive and Negative Syndrome Scale (PANSS) total score) -Change from baseline in psychotic symptoms (PANSS Positive Subscale score) -Change from baseline in psychotic symptoms (PANSS Negative Subscale score) -Change from baseline in psychotic symptoms (PANSS Excited Component score) -Change from baseline in psychotic symptoms (PANSS Marder score) -Change from baseline in clinical global impression -Improvement of clinical global impression -Response rate -Change from baseline in personal and social performance ;Timepoint(s) of evaluation of this end point: -Baseline and Week 52 -Baseline and Week 52 -Baseline and Week 52 -Baseline and Week 52 -Baseline and Week 52 -Baseline and Week 52 -Week 52 -Baseline and Week 52 -Baseline and Week 52 | — |
Countries
Bulgaria, Czech Republic, Estonia, France, Germany, Poland, Romania, Russian Federation, Serbia, Slovakia, Ukraine, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed